Meditative Slow Breathing or Isha Kriya Meditation in Improving Cancer-Related Symptoms in Hospitalized Participants With Cancer

Malignant Neoplasm Clinical Trial

Official title:

Feasibility Study of Meditative Practices in Hospitalized Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445572
• Other study ID #: 2017-0694
• Secondary ID: NCI-2018-0092720
• Status: Completed
• Phase: N/A
• Start date: September 21, 2018
• Est. completion date: August 4, 2020

Study information

• Verified date: August 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial studies how well meditative slow breathing or Isha Kriya meditation works in improving cancer-related symptoms in hospitalized participants with cancer. Meditative slow breathing or Isha Kriya meditation may help to decrease perceived stress and enhance well-being in hospitalized cancer participants.

Description:

PRIMARY OBJECTIVES:

I. Test the feasibility of the meditation practice.

SECONDARY OBJECTIVES:

I. Explore the acceptability of meditation in cancer patients through modified Global Symptom Evaluation (GSE) and on day 7 +/- 1 day and day 28 +/- 3 days.

II. Explore the effect of meditative practices in cancer patients through Edmonton Symptom Assessment Scale (ESAS) on the day of enrolment and a weekly basis until the end of study at four weeks.

OUTLINE: Participants are randomized to 1 of 3 groups.

GROUP I (MSB): Participants are instructed on the meditative slow breathing (MSB) technique and then perform MSB over 15 minutes twice daily (BID) for 28 days.

GROUP II (IK MEDITATION): Participants are instructed on the 3 steps of Isha Kriya (IK) meditation and then perform IK meditation over 15 minutes BID for 28 days.

GROUP III (WAITLIST): Participants are placed on a waitlist and receive standard supportive care for 28 days. After 28 days, participants may crossover to Group II.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 4, 2020
• Est. primary completion date: August 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of malignancy

• Admitted to the hospital

• Able to follow instructions

• Eastern Cooperative Oncology Practice (Eastern Cooperative Oncology Group [ECOG]) score of 3 or below

• Fluency in English

Exclusion Criteria:

• Patients with life expectancy less than 2 months per attending physician or advance practice provider's note or assessment of prognosis

• Patients with cognitive dysfunction

• Patients who are admitted for observation for < 48 hours will be excluded from the study, as one day would be difficult to provide the necessary information

• Patients who are delirious

• Patients who are unable to follow instructions due to their medical condition

• Patients admitted to the intensive care unit

• Patients with ESAS > 4/10 on dyspnea

• Patients requiring oxygen more than 2 liters

• Patients who are current meditation practitioners

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Best Practice
Receive standard supportive care

Procedure:
• Meditation Therapy
Perform MSB
• Meditation Therapy
Perform IK meditation

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the Meditation Practice defined by Recruitment Rate		Day 7
Primary	Feasibility of the Meditation Practice defined by Adherence Rate		Day 7
Secondary	Acceptability of Meditation in Cancer Patients Assessed by Modified Global Symptom Evaluation (GSE)		Day 7 and Day 28
Secondary	Effect of Meditative Practices in Cancer Patients Assessed by Edmonton Symptom Assessment Scale (ESAS)	Scale is from 0 to 10 with 0 being no symptoms to 10 being worse symptoms.; Proportions of participants who consider that the study makes their symptoms better estimated along with a 90% confidence interval for each of the intervention groups. The Linear mixed model used to examine the differential changes over time for ESAS scores among the three groups.	Enrollment and a weekly basis until the end of study at four weeks.

External Links

•   University of Texas MD Anderson Cancer Center Website